CN110538159A - processing technology of valsartan tablets - Google Patents
processing technology of valsartan tablets Download PDFInfo
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- CN110538159A CN110538159A CN201910860812.6A CN201910860812A CN110538159A CN 110538159 A CN110538159 A CN 110538159A CN 201910860812 A CN201910860812 A CN 201910860812A CN 110538159 A CN110538159 A CN 110538159A
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- valsartan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to the technical field of medicines and discloses a processing technology of valsartan tablets, wherein the valsartan tablets are prepared from the following raw material medicines in parts by weight: the valsartan tablet comprises 48 parts of valsartan, 45 parts of corn starch, 6 parts of dextrin, 16 parts of lactose, 30 parts of microcrystalline cellulose, 18 parts of ethanol and 21 parts of starch slurry, and the specific processing steps of the valsartan tablet are as follows: weighing the raw materials according to parts by weight, and placing the raw materials in corresponding containers for later use. According to the processing technology of the valsartan tablets, a complex preparation technology is simplified, some steps are removed, the process difficulty is greatly reduced although the qualification rate of the tablets is reduced, and details are strictly controlled in the preparation technology, so that the qualification rate of the tablets is improved, the qualification rate of the tablets is kept above a normal level after synthesis, the preparation cost is reduced through the simplified technology, and the valsartan tablet processing technology is suitable for being prepared in a plurality of small and medium pharmaceutical factories.
Description
Technical Field
the invention relates to the technical field of medicines, in particular to a processing technology of valsartan tablets.
Background
The valsartan tablet is suitable for treating mild and moderate essential hypertension, has dosage independent of race, age and sex, can be taken at dinning or on an empty stomach, is recommended to be taken at the same time every day, patients with renal insufficiency, non-cholangiogenesis and liver insufficiency without cholestasis do not need to adjust dosage, and can be combined with other antihypertensive drugs, so the valsartan tablet is the first choice of the antihypertensive drugs.
However, the processing cost of the valsartan tablet is high due to the high processing technology and requirements of the valsartan tablet, and the qualification rate of tablets processed by small and medium pharmaceutical factories is insufficient, so that the processing technology of the valsartan tablet is provided.
disclosure of Invention
the invention provides the following technical scheme: a processing technology of a valsartan tablet is disclosed, wherein the valsartan tablet is prepared from the following raw material medicines in parts by weight: the valsartan tablet comprises 48 parts of valsartan, 45 parts of corn starch, 6 parts of dextrin, 16 parts of lactose, 30 parts of microcrystalline cellulose, 18 parts of ethanol and 21 parts of starch slurry, and the specific processing steps of the valsartan tablet are as follows:
S1, weighing the raw materials according to parts by weight, and placing the raw materials in corresponding containers for later use;
s2, introducing the valsartan, the corn starch, the dextrin, the lactose and the microcrystalline cellulose into a shaking sieve for screening, and separately storing the screened raw materials;
S3, introducing all the screened raw materials into a high-efficiency wet granulator, and dry-mixing for 10 minutes;
S4, introducing the ethanol and starch slurry into a high-efficiency wet granulator, performing a wet mixing process, and setting the time to be 25 minutes to obtain tablet particles;
s5, introducing the tablet particles into a fluidized bed dryer for drying, and taking out after 28 minutes;
S6, introducing the dried tablet particles into a tablet press, and selecting a corresponding die to complete the tabletting process;
S7, automatically coating the tablets, introducing the sugar-coated materials into a coating machine, and then performing a coating link to obtain the finished product.
Preferably, in S3, the rotation speed frequency of the efficient wet granulator is set to 14rpm, so that the stirring paddle fully stirs the raw materials and the auxiliary materials entering the storage bin, and under the action of the stirring paddle, the powder of the materials collide with each other and finally reach a fully mixed state.
Preferably, in S4, the rotation speed frequency in the high-efficiency wet granulator is adjusted to 20rpm, the kneading and extrusion of the material by the inner wall of the conical hopper and the paddle of the stirring paddle are enhanced, a liquid bridge is gradually formed to change the material into a loose soft material, and then the material is stirred and mutually rubbed by small pieces of material to finally form spherical particles.
Preferably, the ebullient dryer in S5 is in the feeding stage, in view of the uniformity of drying of the drug particles, when the temperature of the air entering the fluidization chamber must not be too high, typically 30-40 ℃, and when the feeding is completed, the temperature in the fluidization chamber must be allowed to rapidly settle to the set value of 98-102 ℃.
preferably, in S6 the tablet press is required to adjust the depth of the upward drop of the pressure regulator, the greater the depth of the upward drop, the smaller the gap between the upper punch and the lower punch, and thus the greater the pressure between the two, and thus the greater the hardness of the tablet, and the lesser the depth of the downward drop, the lower the hardness of the resulting tablet.
preferably, the glaze material in S7 is made from concentrated syrup at a concentration of 68%, bletilla gum, hydroxypropyl methoxycellulose, acetone and glycerol.
Compared with the prior art, the invention has the following beneficial effects:
according to the processing technology of the valsartan tablets, a complex preparation technology is simplified, some steps are removed, the process difficulty is greatly reduced although the qualification rate of the tablets is reduced, and details are strictly controlled in the preparation technology, so that the qualification rate of the tablets is improved, the qualification rate of the tablets is kept above a normal level after synthesis, the preparation cost is reduced through the simplified technology, and the valsartan tablet processing technology is suitable for being prepared in a plurality of small and medium pharmaceutical factories.
Drawings
Fig. 1 is a process flow diagram of valsartan tablets of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present disclosure more clear, the technical solutions of the embodiments of the present disclosure will be described below clearly and completely with reference to the accompanying drawings of the embodiments of the present disclosure. It is to be understood that the described embodiments are only a few embodiments of the present disclosure, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the disclosure without any inventive step, are within the scope of protection of the disclosure.
unless otherwise defined, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this disclosure belongs. The use of the word "comprising" or "comprises", and the like, in this disclosure is intended to mean that the elements or items listed before that word, include the elements or items listed after that word, and their equivalents, without excluding other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may also include electrical connections, whether direct or indirect.
to maintain the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and known components are omitted so as to not unnecessarily obscure the concepts of the present disclosure.
Referring to fig. 1, a processing process of a valsartan tablet, the valsartan tablet is prepared from the following raw material medicines in parts by weight: the valsartan tablet comprises 48 parts of valsartan, 45 parts of corn starch, 6 parts of dextrin, 16 parts of lactose, 30 parts of microcrystalline cellulose, 18 parts of ethanol and 21 parts of starch slurry, and the specific processing steps of the valsartan tablet are as follows:
S1, weighing the raw materials according to parts by weight, and placing the raw materials in corresponding containers for later use;
S2, introducing the valsartan, the corn starch, the dextrin, the lactose and the microcrystalline cellulose into a shaking sieve for screening, and separately storing the screened raw materials;
s3, introducing all the screened raw materials into a high-efficiency wet granulator, and dry-mixing for 10 minutes;
s4, introducing the ethanol and starch slurry into a high-efficiency wet granulator, performing a wet mixing process, and setting the time to be 25 minutes to obtain tablet particles;
S5, introducing the tablet particles into a fluidized bed dryer for drying, and taking out after 28 minutes;
S6, introducing the dried tablet particles into a tablet press, and selecting a corresponding die to complete the tabletting process;
S7, automatically coating the tablets, introducing the sugar-coated materials into a coating machine, and then performing a coating link to obtain the finished product.
preferably, in S3, the rotation speed frequency of the efficient wet granulator is set to 14rpm, so that the stirring paddle fully stirs the raw materials and the auxiliary materials entering the storage bin, and under the action of the stirring paddle, the powder of the materials collide with each other and finally reach a fully mixed state.
Preferably, in S4, the rotation speed frequency in the high-efficiency wet granulator is adjusted to 20rpm, the kneading and extrusion of the material by the inner wall of the conical hopper and the paddle of the stirring paddle are enhanced, a liquid bridge is gradually formed to change the material into a loose soft material, and then the material is stirred and mutually rubbed by small pieces of material to finally form spherical particles.
Preferably, the ebullient dryer in S5 is in the feeding stage, in view of the uniformity of drying of the drug particles, when the temperature of the air entering the fluidization chamber must not be too high, typically 30-40 ℃, and when the feeding is completed, the temperature in the fluidization chamber must be allowed to rapidly settle to the set value of 98-102 ℃.
Preferably, in S6 the tablet press is required to adjust the depth of the upward drop of the pressure regulator, the greater the depth of the upward drop, the smaller the gap between the upper punch and the lower punch, and thus the greater the pressure between the two, and thus the greater the hardness of the tablet, and the lesser the depth of the downward drop, the lower the hardness of the resulting tablet.
preferably, the glaze material in S7 is made from concentrated syrup at a concentration of 68%, bletilla gum, hydroxypropyl methoxycellulose, acetone and glycerol.
the above embodiments are only exemplary embodiments of the present invention, and are not intended to limit the present invention, and the scope of the present invention is defined by the claims. Various modifications and equivalents may be made by those skilled in the art within the spirit and scope of the present invention, and such modifications and equivalents should also be considered as falling within the scope of the present invention.
Claims (6)
1. a processing technology of a valsartan tablet is disclosed, wherein the valsartan tablet is prepared from the following raw material medicines in parts by weight: 48 parts of valsartan, 45 parts of corn starch, 6 parts of dextrin, 16 parts of lactose, 30 parts of microcrystalline cellulose, 18 parts of ethanol and 21 parts of starch slurry, and is characterized in that the valsartan tablet is specifically processed by the following steps:
s1, weighing the raw materials according to parts by weight, and placing the raw materials in corresponding containers for later use;
S2, introducing the valsartan, the corn starch, the dextrin, the lactose and the microcrystalline cellulose into a shaking sieve for screening, and separately storing the screened raw materials;
S3, introducing all the screened raw materials into a high-efficiency wet granulator, and dry-mixing for 10 minutes;
S4, introducing the ethanol and starch slurry into a high-efficiency wet granulator, performing a wet mixing process, and setting the time to be 25 minutes to obtain tablet particles;
s5, introducing the tablet particles into a fluidized bed dryer for drying, and taking out after 28 minutes;
s6, introducing the dried tablet particles into a tablet press, and selecting a corresponding die to complete the tabletting process;
S7, automatically coating the tablets, introducing the sugar-coated materials into a coating machine, and then performing a coating link to obtain the finished product.
2. the processing technology of valsartan tablets according to claim 1, wherein in the S3, the rotation speed frequency of the efficient wet granulator is set to 14rpm, so that the stirring paddle fully stirs the raw materials and the auxiliary materials entering the storage bin, and under the action of the stirring paddle, the powder materials collide with each other and finally reach a fully mixed state.
3. The processing technology of valsartan tablets according to claim 1, wherein in S4, the rotation speed frequency in the high-efficiency wet granulator is adjusted to 20rpm, the kneading and extrusion of the material by the inner wall of the conical hopper and the paddle of the stirring paddle are enhanced, a liquid bridge is gradually formed to change the material into a loose soft material, and then the materials are stirred and rubbed with each other to form spherical particles.
4. The process of claim 1, wherein the fluidized drying machine in S5 is used to dry the drug particles in a uniform manner, wherein the temperature of the air entering the fluidized chamber is not too high, typically 30-40 ℃, and the temperature in the fluidized chamber must be stabilized between 98-102 ℃ after the feeding process.
5. The process of claim 1, wherein the tablet press is required to adjust the punch-down depth of the pressure regulator in step S6, and the larger the punch-down depth, the smaller the gap between the punch-down depth and the lower punch, and thus the greater the pressure between the punch-down depth and the lower punch, so that the greater the hardness of the tablet, and the smaller the lower the punch-down depth, the lower the hardness of the tablet.
6. The process of claim 1, wherein the sugar coating material in S7 is prepared from 68% concentrated syrup, bletilla gum, hydroxypropyl methoxycellulose, acetone, and glycerol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910860812.6A CN110538159A (en) | 2019-09-11 | 2019-09-11 | processing technology of valsartan tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910860812.6A CN110538159A (en) | 2019-09-11 | 2019-09-11 | processing technology of valsartan tablets |
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| Publication Number | Publication Date |
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| CN110538159A true CN110538159A (en) | 2019-12-06 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201910860812.6A Pending CN110538159A (en) | 2019-09-11 | 2019-09-11 | processing technology of valsartan tablets |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553435A (en) * | 2018-06-08 | 2018-09-21 | 华益药业科技(安徽)有限公司 | A kind of Valsartan piece and preparation method thereof |
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- 2019-09-11 CN CN201910860812.6A patent/CN110538159A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553435A (en) * | 2018-06-08 | 2018-09-21 | 华益药业科技(安徽)有限公司 | A kind of Valsartan piece and preparation method thereof |
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Application publication date: 20191206 |
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| RJ01 | Rejection of invention patent application after publication |